InfoTech Spectrum delivers comprehensive fully integrated creative IT solutions ranging from IT consulting Life Sciences (Validation) , Engineering services to advanced technology deployment and product development. Please forward your resumes to arjuninfotechspectrum.com or reach-out to ext 103. Job Title Senior Validation Engineer Job Description Job Responsibilities Develop Validation Plan to define the validation strategy to be compliant with FDA regulations and Client company policies. Apply Process Validation, Regulatory requirements and Drug development process knowledge and experience to analyze the requirements. Perform the IT Validation activities for FDA regulated applications systems across multiple computing environments. Understand the Client Validation Procedures and Requirements in validating new or modified processes, systems that supports manufacturing in the plant. Lead the planning for all validation testing activities (OQ, PQ and Pre-validation UAT protocols). Develop Test Strategy and Plan in execution of Operational and Performance protocols to meet company policies and procedures. Execute validation test protocols and document the test results. Develop defect reports, and track them for its resolution and maintain Requirements Traceability Matrix (RTM) and Prepare Test Summary Report to summarize all the test activities including any open deviations. Track and monitor review and approval of validation deliverables, participate in meetings with project team and Client Stakeholders as required. Prepare User Requirements, System Requirements including system flow diagram Specifications, Configuration and Design Specifications Participate in internal or external training programs to maintain knowledge of validation principles. Use HP Quality Center for tracking validation activities, test results and test defects. any ELN experience a PLUS Will sponsor if required.
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